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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K223788
Device Name The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter
Applicant
Medsource International, LLC
8600 Shelby Court
Suite 100
Chanhassen,  MN  55317
Applicant Contact Amanda Salentine
Correspondent
Medsource International, LLC
8600 Shelby Court
Suite 100
Chanhassen,  MN  55317
Correspondent Contact Emilie Andrews
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/19/2022
Decision Date 09/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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